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Product NDC Code | 70626-202 | ||||||||
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Drug Name | Daily shield broad spectrum spf 20 moisturizer |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LOTION | ||||||||
Application Number | part352 | ||||||||
Labeler Name | ASPIRE BRANDS INC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS AVOBENZONE 3.0% HOMOSALATE 10.0% OCTISALATE 5.0% OCTOCTYLENE 7.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING REAPPLY AT LEAST EVERY 2 HOURS CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER, BUTYLENE GLYCOL, TRIBEHENIN PEG-20 ESTERS, ISOCETYL STEAROYL STEARATE, DIMETHICONE, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL ALCOHOL, POLYETHYLENE, LAURETH-4, CAPRYLYL GLYCOL, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, PENTYLENE GLYCOL, PEG-100 STEARATE, GLYCERYL STEARATE, GLYCERIN, HYDROGENATED LECITHIN, ACYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SODIUM HYDROXIDE, ISOHEXADECANE, HEXYLENE GLYCOL, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, SODIUM ASCORBYL PHOSPHATE, PUNICA GRANATUM FRUIT EXTRACT, HYDROLYZED JOJOBA ESTERS, DISODIUM EDTA, ALLYL METHACRYLATES CROSSPOLYMER, POLYSORBATE 80, N-PROLYL PALMITOYL TRIPEPTIDE-56 ACETATE, SODIUM HYALURONATE, YELLOW 5, RED 40.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USE HELPS PREVENT SUNBURN IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.
Purpose
Information about the drug product’s indications for use.PURPOSE SUNSCREEN
Spl product data elements
Usually a list of ingredients in a drug product.DAILY SHIELD BROAD SPECTRUM SPF 20 MOISTURIZER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WATER BUTYLENE GLYCOL TRIBEHENIN PEG-20 ESTERS ISOCETYL STEAROYL STEARATE DIMETHICONE SHEA BUTTER CETYL ALCOHOL LOW DENSITY POLYETHYLENE LAURETH-4 CAPRYLYL GLYCOL POTASSIUM CETYL PHOSPHATE PHENOXYETHANOL PENTYLENE GLYCOL PEG-100 STEARATE GLYCERYL MONOSTEARATE GLYCERIN HYDROGENATED SOYBEAN LECITHIN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) SODIUM HYDROXIDE ISOHEXADECANE HEXYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE SODIUM ASCORBYL PHOSPHATE POMEGRANATE HYDROLYZED JOJOBA ESTERS (ACID FORM) EDETATE DISODIUM ALLYL METHACRYLATE POLYSORBATE 80 N-PROLYL PALMITOYL TRIPEPTIDE-56 ACETATE HYALURONATE SODIUM FD&C YELLOW NO. 5 FD&C RED NO. 40 AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.01b UC_Daily Shield SPF20_45mL 0-Image_Daily Shield SPF-20_45mL
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? CALL 1-866-984-1433
Storage and handling
Information about safe storage and handling of the drug product.PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS FOR EXTERNAL USE ONLY DO NOT USE ON DAMAGED OR BROKEN SKIN STOP USE AND ASK A DOCTOR IF RASH OCCURS. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API